A prospective, open label study to evaluate the safety, efficacy of KAL-HS-01 in Reducing Symptoms of arthritis (Sandhigata Vata) and in maintaining Optimal Joint Health
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy/ perceived benefit of JOINT CARE in the following:
研究概览
简要总结
Keralaayurveda R&D team has developed unique formulation for RHEUMATIC PAIN, JOINTSWELLING, MUSCLE PAIN and JOINT & MUSCLE STIFFNESS.
Non-steroidalanti-inflammatory drugs (NSAIDs) are the most commonly used drugs for thesymptomatic treatment of pain in OA. However, NSAIDs are associated withserious gastrointestinal adverse effects which limit their use in many patients. Other drugs like opioids and non-opioid analgesics and intra-articularsteroids may not be effective in all patients Hence, there is a specific needfor effective and safe drugs in the treatment of OA.
Herbal medicines havebeen explored for their usefulness in OA for a long time. Osteoarthritis, alsoknown as degenerative joint disease (DJD), is the most common type ofarthritis. leaves of Woodfordia fruticosa afford anti-inflammatory activity bypreventing the inflammation in different animal models.Aqueous extract of Withaniasomnifera produced significant reduction in 60 knee joint painpatients.
A few medicinal herbshave a place to mention in the ayurvedic books for their individual anti-inflammatoryactivity. The present study is aimed to see a combination of a few such herbalmedicinal plants for their efficacy in knee pain and joint health
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing to give informed consent.
- •2.Healthy Indian male/ female volunteer aged between 18-65 years.
- •3.Must be able to adhere to the study visit schedule and other protocol requirements.
- •4.Willing to complete the questionnaires for the total duration of 45 days.
- •5.Joint and muscle pain in the last 1 month.
- •6.Willing to avoid usage of pain relievers like Ibuprofen, Acetaminophen or any other NSAIDs etc.
- •during the study duration.
- •7.Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
排除标准
- •1.Pregnant or Breast feeding.
- •2.Inability to provide voluntary consent 3.Patients with pre existing severe systemic disease like uncontrolled diabetes hypertension Cardiac illness etc necessitating long term medication 4.Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation 5.Any clinically significant medical history medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol 6.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 7.Use of any anti psychotic drugs for one week prior to Baseline 8.Subjects who abuse drugs or alcohol drug screening not required 9.Use of any investigational medication within 4 weeks prior to start of study drug.
- •10.Greater than moderate alcohol use.
结局指标
主要结局
To evaluate the efficacy/ perceived benefit of JOINT CARE in the following:
时间窗: Day 0 to Day 56
1.RHEUMATIC PAIN
时间窗: Day 0 to Day 56
2.JOINT SWELLING
时间窗: Day 0 to Day 56
3.MUSCLE PAIN
时间窗: Day 0 to Day 56
4.JOINT & MUSCLE STIFFNESS.
时间窗: Day 0 to Day 56
•% Improvement in the knee pain assessed through VAS [Time: Day 0 to Day 56]
时间窗: Day 0 to Day 56
•% Change in the joint swelling assessed by the Investigator [Time: Day 0 to Day 56]
时间窗: Day 0 to Day 56
次要结局
- •% Improvement in the muscle pain assessed through VAS [Time: Day 0 to Day 56](•% Improvement in the joint and muscle stiffness assessed by the investigator [Time: Day 0 to Day 56])